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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06312774
Other study ID # IRAS 333853
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 18, 2024
Est. completion date January 4, 2027

Study information

Verified date March 2024
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life. The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia. The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 49
Est. completion date January 4, 2027
Est. primary completion date November 7, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients diagnosed with chronic lung disease (= 18years). 2. Only patients who are willing and able to provide informed consent to participate in the study. Exclusion Criteria: 1. Patients with other major comorbidities that could significantly impact muscle mass and function, such as severe heart failure, advanced liver or kidney disease, uncontrolled diabetes, or malignancies. 2. Patients with acute exacerbations of their chronic lung disease or any other acute illness at the time of the study. 3. Patients with a history of neuromuscular disorders or disability that could significantly affect muscle mass and function. 4. Patients who have undergone recent surgery in the past 6 months or have received specific treatments that could influence muscle mass and function, such as long-term corticosteroid use, chemotherapy, or radiation therapy. 5. Patients with life expectancy of less than 6 months 6. Patients who are unable or unwilling to comply with the study protocol or procedures. 7. Patients that are unable to give informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
This is observational study
This is observational study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Outcome

Type Measure Description Time frame Safety issue
Primary Sarcopenia feasibility of using the FACS approach and molecular analyses to investigate the association between sarcopenia and chronic lung disease 3 years
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